]]>On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary recall. Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made plans in advance of a recall so that they are prepared, should one become necessary.

How to be “Recall Ready”

In order to facilitate timely initiation of a voluntary recall, the draft guidance recommends firms make the following preparations:

Designate specific employees with recall-related responsibilities who possess the authority to take the steps needed to implement a product recall when necessary.

Train personnel on recall-related responsibilities, and consider additional preparatory steps such as mock recalls and establishing metrics appropriate to a recall plan.

Create a recall communications plan that identifies specific points-of-contact, and that contains draft templates that help the firm issue recall communications promptly.

Identify possible recall-associated reporting requirements, for circumstances when a significant problem with a distributed product may trigger a requirement to make a separate report to FDA, g., a report to the Reportable Food Registry or reports under 21 CFR 806 for medical devices.

Ensure adequate product coding to make possible positive lot identification and to facilitate the effective recall of all violative lots.

Maintain product distribution records for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention. The records should contain enough detail to identify the consignees that actually received the recalled product and must conform to any applicable requirements.

The draft guidance further advises a firm to maintain written recall initiation procedures that assign responsibility and describe the steps to perform all actions related to initiating a recall, as appropriate to the specific products and business model of the firm or facility. These procedures should include actions such as (1) ceasing distribution, shipment or sales of affected product; (2) developing a recall strategy; (3) notifying direct consignees; and (4) when appropriate, notifying the public of the recall.

Steps for responding to an indication of a problem

The draft guidance outlines specific steps a firm should take if there is an indication of a problem with a distributed product:

Identify the problem using indicators such as an internal report of a product specification deviation or out-of-specification testing results for a product.

Promptly investigate the problem to ensure that potential risks are consistently assessed and investigated for products potentially affected.

Make decisions about whether a recall is necessary, and if so, about the scope and depth of that recall.

This draft guidance is part of a series of policy steps FDA is taking to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls, as we recently discussed in a February 26 alert. FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said in a press release that “there is more that needs to be done,” adding that FDA “will continue its efforts to improve recalls, and will encourage the use of new technologies and other tools that can assist in those efforts.”

The voluntary recall draft guidance is open for public comment until June 24; please contact any of the above-listed authors if you have any questions about the guidance or may be interested in commenting. We will continue to keep you apprised of new FDA efforts to inform companies on proper procedures for voluntary recalls.

]]>FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing siteshttps://www.hlregulation.com/2018/09/05/fda-publishes-internal-policy-on-prioritizing-surveillance-inspections-for-drug-manufacturing-sites/
Wed, 05 Sep 2018 18:59:10 +0000https://www.hlregulation.com/?p=10726Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug

]]>Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug establishments, FDA conducted 1,453 drug surveillance inspections. Accordingly, this site selection policy (and the accompanying Site Selection Model (SSM)) is intended to clarify how FDA prioritizes inspections of sites that pose the greatest potential risks to patients. While certain elements of this policy could be gleaned from prior public statements or presentations from FDA regarding the agency’s risk-based inspectional strategies and resource allocation, the announcement is significant in that it memorializes in a formal policy document FDA’s approach for prioritizing and scheduling surveillance inspections.

Key takeaways from this policy document include:

FDA’s Office of Surveillance is responsible for maintaining and applying the SSM, and generating a Site Surveillance Inspection List (SSIL). FDA’s Office of Regulatory Affairs is responsible for planning and conducting inspections based on the SSIL.

The SSM will be applied equally to domestic and foreign establishments. FDA’s goal is “to achieve parity in inspection frequency, meaning equal frequency for sites with equivalent risk, regardless of geography (foreign or domestic).”

To further FDA’s Mutual Recognition Agreement with the EU, the SSM will consider whether a particular establishment has been inspected by a foreign regulatory authority determined to be capable by FDA. (We most recently discussed FDA’s recognition of inspectional data from EU regulatory authorities here).

Manufacturing sites on OAI status and manufacturing sites currently on Import Alert are not included in FDA’s surveillance inspection planning; these sites are subject to inspection according to FDA’s enforcement policies.

Drug quality matters. A key risk component in the SSM is hazard signals, including Field Alert Reports, Biological Product Deviation Reports, MedWatch reports, and recalls. Indeed, based on our recent experience, hazard signals may be the key risk component for moving up FDA’s SSIL.

Newly registered sites should expect to be inspected within 30 days after registering with FDA.

In addition to the implicit exclusions from the SSM noted above (i.e., sites on OAI status), certain establishments are expressly excluded from the SSM, including registered outsourcing facilities, medical gas sites, inactive ingredient manufacturers, and manufacturers of drugs intended for use only in clinical trials.

]]>UK Government publishes first no-deal Brexit notices for foodhttps://www.hlregulation.com/2018/08/24/uk-government-publishes-first-no-deal-brexit-notices-for-food/
Fri, 24 Aug 2018 15:10:48 +0000https://www.hlregulation.com/?p=10721The Government has released its first batch of technical notices which aim to prepare UK citizens and businesses for an exit from the EU without a Withdrawal Agreement on 29 March 2019. Of most relevance to food businesses are the notices on developing genetically modified organisms (“GMOs“) and producing and processing organic foods. Under the

Under the European Union (Withdrawal) Act 2018, existing UK laws implementing European Regulations and Directives will continue to apply after the UK leaves the EU. Existing legislation will be amended so it functions effectively in the new UK-only context, for example, by replacing references to the UK as a Member State.

With regard to GMOs, this means there will be few significant implications in the event of a “no-deal” scenario. The release of GMOs will continue to require prior authorisation, which will only be granted if there are no safety concerns, as is currently the case under EU Directive 2001/18. These decisions will continue to be taken in the UK, as will regulatory decisions on marketing GMOs which have previously been made at EU level. Any EU decisions authorising the marketing of GMOs which are in force the day the UK leaves the EU will continue to apply until the expiry of the current EU consent period.

The main difference to the current regime is that the UK will be treated as a third country by the EU for trade purposes. Therefore, UK businesses will only be able to export GMO products to the EU if the GMO in question has EU marketing approval. Similarly, EU GMO exports to the UK will be dependent on the products having marketing approval in the UK. Over time, this may result in increased barriers to trade between the UK and the EU. However, overall, the impact on food businesses in the UK is likely to be low given that the only GM crop seed currently approved for commercial cultivation in the EU (MON 810 Maize) is not currently marketed or grown in the UK.

The Government anticipates more upheaval in the organic food sector. It confirms that the UK will continue to maintain high standards in food production and labelling and that UK organic control bodies will still be responsible for certifying UK organic operators. It also plans to continue accepting imports of EU organic products as well as those from countries with equivalent standards such as the USA, Canada, Japan and South Korea (although, this remains at the UK’s discretion). Nonetheless, there will be a number of substantial changes in the event of a no-deal Brexit because the UK will be treated as a third country. Notably:

Food labelling will need to change as UK organic operators will no longer be able to use the EU organic logo. There will be a grace period to during which existing stock can be sold through, but the UK will need to develop its own logo for use on organic products.

A new traceability system will replace the current EU TRACES NT system to ensure the traceability of organic food and feed imported into the UK. More information on the replacement system is expected in the coming weeks.

Export restrictions will be placed on UK businesses, which will only be able to export to the EU if they are certified by an organic control body recognised and approved by the EU. Problematically, UK control bodies cannot apply to the EU for recognition until the UK becomes a third country and approval can take up to nine months. The Government intends to negotiate an equivalency arrangement with the EU which will allow the free movement of organic goods between the EU and the UK in the meantime. However, if it fails to do so, this may leave the UK unable to export organic products to the EU for nearly one year post-Brexit.

Overall, the notices stress the Government’s confidence in its ability to negotiate a successful deal with the EU and maintain that these are merely contingency plans to enable UK businesses to prepare for the worst-case scenario. However, whilst providing some initial guidance, the notices suggest that there continues to be a significant degree of uncertainty regarding the UK’s position in the event of a no-deal Brexit. In particular, there does not yet seem to be a viable plan to ensure continuing trade of organic products between the UK and the EU27 on Day 1.

A further 50 or so notices are expected to be published before the end of September. As 29 March 2019 looms closer, businesses should continue to monitor these carefully and consider how they will respond to a “no-deal” outcome to ensure continuity in their operations.

]]>“New Deal for Consumers” – draft package adopted by the European Commissionhttps://www.hlregulation.com/2018/04/17/new-deal-for-consumers-package/
Tue, 17 Apr 2018 16:53:59 +0000https://www.hlregulation.com/?p=10457The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market. The package was adopted by the Commission in response to an evaluation on EU consumer protection and marketing directives. The evaluation found such laws need to be better applied, enforced

]]>The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market.

The package was adopted by the Commission in response to an evaluation on EU consumer protection and marketing directives. The evaluation found such laws need to be better applied, enforced and modernised for the digital age.

The new package published on 11 April 2018 includes two new proposed directives (the “Directives“):

a directive on better enforcement and modernisation of EU consumer protection rules; and

a directive on representative actions for the protection of the collective interests of consumers.

The Directives could have a significant impact on the enforcement and protection of consumer rights. Consumer facing businesses will need to be mindful of the Directives as they progress through the EU legislative process.

The main aims of the package include:

Modernising consumer rules to respond to current challenges.

The proposals seek to extend consumer protections to “free services” (such as cloud storage and social media accounts) where consumers provide their personal data, rather than monetary payment in return for services. The Commission is also looking to remove disproportionate burdens for traders, for example, traders could choose more flexible means of communicating with consumers e.g. via web chats.

Better redress opportunities for consumers and supporting effective enforcement of public authorities.

The “New Deal for Consumers” package would allow consumers to claim through mass representative actions in “mass harm situations” (i.e. situations that affect large numbers of consumers in the EU). The proposals would also allow national authorities to impose a fine of at least 4% of the trader’s turnover for widespread cross-border infringements.

Improving awareness of consumer rights and helping traders to comply with their obligations.

The Commission is looking to run campaigns to help Europeans become more aware of their consumer rights. Such campaigns will focus on Member States where consumers’ knowledge of their rights is at the lowest. The proposals also seek to introduce a number of online tools to assist traders understand what they need to do to comply with their obligations.

Ensuring equal treatment of consumers and empowering national authorities to tackle issues with “dual quality” of consumer products.

The Commission has already adopted guidelines on the application of EU food and consumer laws to address the issue of “dual quality” products. The “New Deal for Consumers” package looks to make it difficult and costly for traders who mislead consumers by marketing “dual quality” goods by introducing stricter penalties for illegal practices, individual remedies for misled consumers and collective redress mechanisms.

Increasing cooperation with partner countries outside the EU.

The proposals look to increase international cooperation with partners outside the EU. For example, the Commission intends to co-ordinate consumer protection enforcement with key jurisdictions such as US, Canada and potentially China.

Preparing consumer policy for future challenges.

The proposals highlight Artificial Intelligence, the Internet of Things and Mobile e-commerce as emerging challenges for consumer protection law. The Commission states it will continue to monitor consumer markets and develop behavioural insights to inform its policymaking on future challenges.

The “New Deal for Consumers” package is a priority for this Commission which seeks to finalise the Directives before May 2019. The UK has also recently published a green paper on modernising consumer markets (see our blog here).

]]>UK ‘Sugar Tax’ Comes into Force – New Guidance Published for Industryhttps://www.hlregulation.com/2018/04/06/uk-sugar-tax-comes-into-force-new-guidance-published-for-industry/
Fri, 06 Apr 2018 09:22:14 +0000https://www.hlregulation.com/?p=10454The UK tax authority HM Revenue and Customs (HMRC) has published a series of practical guidance documents and additional online information to assist companies with understanding and complying with the new UK ‘Soft Drinks Industry Levy’, which takes effect from 6 April 2018. The new levy applies to all soft drinks (other than natural fruit

]]>The UK tax authority HM Revenue and Customs (HMRC) has published a series of practical guidance documents and additional online information to assist companies with understanding and complying with the new UK ‘Soft Drinks Industry Levy’, which takes effect from 6 April 2018.

The new levy applies to all soft drinks (other than natural fruit juice, vegetable juice, milk and certain alcoholic drinks) packaged in or imported to the UK, that contain added sugar and at least 5 grams of sugar in total (both naturally occurring and added sugar) per 100ml of prepared drink (“chargeable drinks”). There are two rates – £0.18 per litre for drinks containing 5g or more total sugars per 100ml, rising to £0.24 per litre for drinks containing 8g or more total sugars per 100ml.

Companies that produce, package or receive imported chargeable drinks will need to register with HMRC and keep detailed records of products that are subject to the levy. The online registration system is now up and running.

]]>Rules of Origin: a ‘hidden hard Brexit’ for the UK food industry?https://www.hlregulation.com/2018/04/05/rules-of-origin-a-hidden-hard-brexit-for-the-uk-food-industry/
Thu, 05 Apr 2018 10:55:02 +0000https://www.hlregulation.com/?p=10448The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit. Rules of origin are the detailed content requirements that determine whether goods are

]]>The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit.

Rules of origin are the detailed content requirements that determine whether goods are produced “locally” in order to benefit from preferential tariff rates. Food manufacturing is an internationalised business, with UK producers regularly sourcing ingredients from across the EU and globally, often because sourcing equivalent ingredients in the UK would not be economically or practically feasible.

To date, the UK has benefited from the absence of origin requirements for trade within the EU. However, after Brexit, while it is expected that the EU and UK will negotiate largely or complete free tariffs on food and drink under a preferential free trade agreement (“FTA“), the ability of UK exporters to benefit from those rates will depend on whether their goods meet the criteria to be classified as UK products. Depending on the outcome, many UK producers who have built supply and distribution models on the basis of the single market framework may find that they no longer comply with the permitted levels of global ingredients and may therefore be ineligible for preferential trade terms and tariffs.

Because the EU and the UK are likely to maintain high basic tariffs for food and drink products, the margin between preferential treatment and non-preferential treatment is likely to be considerable. As a result, FDF argues that producers excluded from preferential terms will face a ‘hidden hard Brexit’ and may face costly restructuring of supply chains, absorption of higher costs or de facto barring from EU-UK trade, potentially requiring a restructuring of operations to avoid cross-border trade altogether.

To reduce this risk, the report sets out eight rules of origins provisions that the UK should seek to include in an EU-UK FTA to ensure any new origin rules are suitable for the globalised industries they will impact. The proposals include:

a de minimis allowance for non-local content in all goods, set at 10% of the value in addition to any other product-specific allowances;

cumulative origin requirements, meaning that goods originating in either the UK or EU are treated as originating in both for the purposes of meeting origin requirements;

origin protocols reflecting the unique value added by high quality manufacturing, established brands and other forms of technological input that often characterise the EU and UK food and drink sectors and contribute to a price premium for these goods; and

a simplification of the administrative burden of complying with origin requirements through wider use of self-certification, extended validity for origin designations and exemptions for low value shipments.

As a major producer and exporter of food and drink both to the EU and globally, failure to secure preferential treatment under an FTA will be costly for the UK and could have knock-on effects across the food and drink sector. Any solution will need to effectively balance the importance of encouraging local production with the reality of global production in order to prevent serious disruption to existing supply and distribution chains.

]]>European Commission Publishes Guidance on Brexit and UK Food Exportshttps://www.hlregulation.com/2018/02/06/european-commission-publishes-guidance-on-brexit-and-uk-food-exports/
Tue, 06 Feb 2018 15:17:30 +0000https://www.hlregulation.com/?p=10332On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a ‘third country’ from the date of its withdrawal from the EU. This will impact a number of

]]>On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a ‘third country’ from the date of its withdrawal from the EU. This will impact a number of key areas of EU food regulation, including:

Food labelling: changes will need to be made to labels of food products originating from the UK. An EU-based importer must be named on the product, and mandatory references to the origin of products will need to be changed from “EU” to “UK” or “non-EU”.

Food composition, contaminant levels and food contact materials: UK-produced food sold in the EU will remain subject to EU rules including requirements for certain ingredients to be authorised by the Commission (e.g. additives and flavourings and novel foods), maximum permitted levels of contaminants and residues in foodstuffs, and rules on food contract materials. These apply to all foods placed on the EU market, irrespective of the place of production.

EU establishment requirements and submission of EU authorisations: some products such as genetically modified food must have a food business operator, authorisation holder or a representative that is established in the EU. Establishments in the UK will no longer comply with this requirement. The Food Standards Agency, the UK’s competent authority, will also no longer be able to accept applications for EU authorisations such as for the cultivation and placing on the market of genetically modified materials, and for use of new materials in food contact materials.

Food of animal origin: the import of food of animal origin from the UK into the EU will be prohibited, unless certain requirements are met. These include:

the UK must be listed by the Commission as an approved third country for the export of each category of food of animal origin. The Commission has not addressed whether the UK will automatically be approved post-Brexit or whether the UK will need to apply for authorisation as a third country;

the establishment from which the food is dispatched and obtained or prepared must further be approved for the export of the specific category of food of animal origin;

the imported food satisfies all EU food hygiene requirements; and

the product will be subject to mandatory border checks and must enter the EU through approved border inspection posts of a remaining Member State.

Organic products: UK-originating organic foods will be subject to the same regulation as organic foods entering the EU from other third countries. In particular, all consignments of organic products must be accompanied by a certificate of inspection on import to the EU. These certificates can be issued by an authorised EU organic control body or authority or a non-EU control body or authority recognised as having equivalent standards as the EU. Certificates issued by UK bodies will no longer be valid.

]]>The Decision Is In, and South Africa Will Soon Tax the Sugar Content of Beverageshttps://www.hlregulation.com/2017/12/07/the-decision-is-in-and-south-africa-will-soon-tax-the-sugar-content-of-beverages/
Thu, 07 Dec 2017 22:37:03 +0000https://www.hlregulation.com/?p=10236Following the 2016 budget speech during which the proposal to tax the sugar content of beverages was first tabled, and after 18 months of vigorous debate, the South African Parliament on Tuesday adopted the taxation of sugary drinks.

]]>Following the 2016 budget speech during which the proposal to tax the sugar content of beverages was first tabled, and after 18 months of vigorous debate, the South African Parliament on Tuesday adopted the taxation of sugary drinks.

According to Treasury, the sugar tax is motivated by the high consumption of sugary beverages in South Africa, and which impact levels of obesity, and further contributes to an increase in non-communicable diseases such as diabetes and hypertension.

Various countries across the globe are taxing sugary drinks and, by way of example, the United Kingdom’s tax authority has recently published draft Regulations setting out further details in respect of the levies to be imposed on their soft drinks industry.

From 1 April 2018, the sugar content of beverages will be taxed at a rate of 2.1 cents per gram of sugar, and calculated above the threshold of 4 grams of sugar per 100ml of the beverages manufactured in, or imported into, South Africa.

In comparison, the United Kingdom draft Regulations will impose a levy on beverages that contain added sugar and at least 5 grams of sugar per 100ml of prepared drink. A levy of 18 pence per litre will apply, rising to 24 pence per litre for chargeable drinks containing 8 grams of sugar or more, per 100ml. Although the South African threshold is less than the United Kingdom’s threshold, it appears that the levy calculation method and rates are comparable.

Although many are concerned regarding the potential impact that the sugar tax may have on the South African beverage industry as a whole, and in particular employment levels within the industry, others are singing Treasury’s praises, and have made it clear that the rate of the sugar tax should be further increased in the future.

For the time being, and on average, a can of sugary soda will cost South African consumers an additional 11 percent.

]]>One step closer to new rules on organic farminghttps://www.hlregulation.com/2017/11/30/one-step-closer-to-new-rules-on-organic-farming/
Thu, 30 Nov 2017 15:46:18 +0000https://www.hlregulation.com/?p=10220After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonise the rules for organic food production and the labelling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the

]]>After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonise the rules for organic food production and the labelling of organic products.

Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the EU, as well as the national inspection and certification systems that ensure that these requirements are met.

However, the past decade has seen a 125% growth in the value of the organic food market, with the amount of land used for organic farming growing at around 400,000 hectares per year. The European Commission has now recognised that the current rules need to be updated to support the long term development of organic production in the EU.

One of the key aims of the new regulations will be to ensure that the EU organic logo offers consumers the same guarantee of quality across Europe, including in respect of products imported from outside the EU.

The new rules will:

Create an EU-wide set of rules for all organic producers and products. Any necessary exceptions will be limited in time, regularly assessed and applied to all producers to ensure fair treatment.

Apply equally to non-EU farmers who export their goods to the EU, phasing out the 60+ different “equivalence” standards currently applying to imported organic foods and levelling the playing field between EU and non-EU producers.

Enable farmers to apply for group certification for their products, thereby reducing costs and making it easier to join the organic scheme.

Apply to new products like salt, cork and essential oils and enable further products to be added in response to consumer demand.

Allow national authorities the discretion to reduce controls and inspections on farms from every year to every two years for producers with no record of non-compliance after three consecutive controls.

Reinforce the rules on precautionary measures to avoid accidental contamination by pesticides, giving consumers confidence that no pesticides have been used in the production of organic foods.

Following the European Parliament’s first reading, the proposed regulations will come into force on 1 January 2021, repealing Council Regulation (EC) 834/3007.

]]>UK ‘Sugar Tax’ – Draft Regulations Publishedhttps://www.hlregulation.com/2017/11/16/uk-sugar-tax-draft-regulations-published/
Thu, 16 Nov 2017 12:08:02 +0000https://www.hlregulation.com/?p=10196The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018. The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5

]]>The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018.

The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5 grams of sugar in total (both naturally occurring and added sugar) per 100ml of prepared drink (“chargeable drinks”). A levy of 18p per litre will apply, rising to 24p per litre for chargeable drinks containing 8 grams or more of sugar per 100ml.

Companies that produce, package or receive imported chargeable drinks will need to register with HMRC and keep detailed records of products that are subject to the levy. There is an exemption for companies that produce fewer than 1 million litres of chargeable soft drinks in the relevant tax year.

The draft Regulations provide further details as to how the levy will be applied in practice, including:

definitions of fruit juice, vegetable juice and milk for the purposes of determining the source of added sugar (as the levy does not apply if the source of added sugar is solely from these ingredients);

how HMRC will calculate the sugar content of drinks intended to be diluted (e.g. cordials) in the absence of a serving dilution ratio on the packaging or where it believes that the suggested ratio has been set specifically to avoid the tax;

details of the registration process, the procedure for submitting returns to HMRC and the payment of charges; and

the procedure for claiming tax credits in relation to chargeable drinks that are exported from the UK or lost or destroyed.

The draft Regulations are available here and the consultation closes on 8 December 2017.